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Orphan drugs dominate FDA’s record-breaking year

Gottlieb also promises to speed biosimilars and cell and gene therapies in 2019

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Shire bags US approval for constipation drug Motegrity

Approval is boost as Takeda takeover nears completion

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Astellas, Catalyst approvals set up record year for FDA approvals

2018 is already well ahead of last year's tally

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Loxo, Bayer get FDA okay for biomarker-driven cancer drug

A first for Loxo, and a second mutation-based targeted drug

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FDA clears Sobi’s Gamifant for ‘hyper-inflammation’ disease

Approval adds to growing US portfolio

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Roche’s new flu pill Xofluza approved in US

First novel treatment in decades, but hasn't shown superiority to Tamiflu

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Leadiant gets FDA OK for bubble boy disease drug

New therapy will rival Orchard's Strimvelis

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FDA approval gained, Pfizer sets sights on first-line NSCLC market

Vizimpro could challenge Tagrisso, survival data will be key

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Teva wins FDA OK for crucial migraine drug

Vital to Teva's turnaround, Ajovy will challenge Novartis/Amgen's Aimovig

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AZ nabs US approval for new leukaemia drug Lumoxiti

Adds to firm's growing oncology franchise

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AbbVie’s blockbuster-in-waiting for endometriosis gets FDA nod

First new oral treatment in more than 10 years

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US approval for first ever cannabis-based medicine

UK company's Epidiolex tipped to be blockbuster

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